Name Dimestin. Release formGel. MNN Dimethinden. Qualitative and quantitative composition The gel contains: active ingredients: dimethindene maleate 1.0 mg; excipients: purified water, propylene glycol, carbopol 940, isopropyl alcohol, sodium hydroxide, benzalkonium chloride (50% solution), disodium edetate. Brief description of the finished dosage formColorless, soft, odorless, homogeneous gel. Pharmacotherapeutic group Anti-itching agents, including antihistamines, anesthetics, etc. Antihistamines for external use. ATC code: D04AA13 Pharmacological properties Pharmacodynamics Gel Dimestin has antihistamine, antiallergic, and antipruritic action. The active substance of Dimestin is dimethindene maleate – a blocker of H1-histamine receptors, which prevents the implementation of the action of histamine by the mechanism of reversible competitive inhibition. Dimestin eliminates the manifestations of skin-allergic reactions associated with the release of histamine: reduces the increased permeability of capillaries and swelling of tissues, reduces irritation and itching, and also has a pronounced local anesthetic effect. It has an antikinin and weak anticholinergic effect. Pharmacokinetics Absorption: Dimestin gel quickly penetrates the skin and exerts its antihistamine effect within a few minutes. The maximum activity is reached in 1-4 hours. After topical application, the systemic bioavailability of dimethindene maleate in healthy volunteers was about 10% of the dose received. Distribution: upon reaching the systemic circulation, the degree of binding of dimethindene to plasma proteins is about 90%. Biotransformation and elimination: Dimetindene is partially biotransformed in the liver and excreted, including in the form of inactive metabolites, in the urine and bile. Clinical properties Indications for use Skin itching of various origins, for example, after insect bites, with light burns of a small area, including sunburn, localized mild allergic skin diseases. Method of application and dosageApplied externally. Adults and children over 2 years of age: The gel is applied in a thin layer to the affected area of the skin 2 to 4 times a day and gently rubbed in. Children under 2 years of age: Dimestin can only be used as directed by a doctor. Contraindications Hypersensitivity to dimethindene, other alkylamine derivatives or excipients of the drug. An allergic reaction to an insect bite in history (in this case, systemic agents are used). neonatal period. I trimester of pregnancy. Application to open or inflamed wounds, weeping areas with skin diseases, mucous membranes, as well as areas of the skin around the eyes. Precautions In case of severe itching or damage to large areas of the skin, the drug can be used only after consulting a doctor. If during the period of application of Dimestine gel, the severity of the symptoms of the disease does not decrease or, on the contrary, increases, you should consult a doctor. II and III trimesters of pregnancy Application of the gel on large areas of the body surface should be avoided. Breast-feeding period Should not be applied to large areas of the skin and the area of the nipples of the mammary glands. Pediatric practice It is not recommended to apply the gel to large areas of the skin surface, especially in young children. Sun exposure After applying the gel, it is recommended to avoid exposure to sunlight on the treated areas of the skin. The preparation contains propylene glycol and benzalkonium chloride, which can irritate the skin. Interactions with other medicinal products have not been described. Use during pregnancy and lactation The use of Dimestine in the first trimester of pregnancy is contraindicated. In the II and III trimesters of pregnancy, as well as during lactation, application of the gel to large areas of the body surface should be avoided. Nursing mothers should not apply the drug to the area of the nipples of the mammary glands. Impact on the ability to drive vehicles and work with dangerous devices and mechanisms No possible adverse effects of dimethindene in the form of a gel for topical use on the ability to drive vehicles and work with dangerous devices and mechanisms have been reported. Side effects The frequency of adverse reactions is indicated in accordance with the following classification: very frequent (≥1 / 10), frequent (≥1 / 100, Skin and subcutaneous tissue disorders: rarely – dryness, burning sensation at the site of application; very rarely – skin rash and itching.On the part of the immune system:very rarely – allergic dermatitis.If these adverse reactions occur or a reaction not described in the instructions for medical use, you should consult a doctor.Overdose Cases of overdose of external forms of dimethindene are not described.Due to low systemic absorption with local use, the risk of overdose is extremely small.In case of accidental ingestion of large amounts of dimethindene in the form of a topical gel, symptoms characteristic of an overdose of antihistamines are observed: depression of the central nervous system with drowsiness (especially in adults), stimulation of the central nervous system and antimuscarinic effects (especially in children ) with agitation, ataxia, hallucinations nations, tonic-clonic convulsions, mydriasis, dry mouth, flushing of the face, urinary retention and fever. It is also possible the development of arterial hypotension. The specific antidote is not known. Treatment: standard emergency measures, including the use of activated charcoal, saline laxatives, and stabilization of the respiratory and cardiovascular system. Stimulants should not be used; vasopressors may be used to increase blood pressure. Carcinogenicity, Mutagenicity and Reproductive Effects Reproductive studies have not shown any embryo-lethal or teratogenic effects of dimethindene when administered to rats (up to 200 mg/kg/day orally or 16 mg/kg/day intravenously) and rabbits (in up to 50 mg/kg/day orally). Embryotoxic properties have been identified in rats: with the introduction of the maximum dose, a decrease in the weight of the offspring and some delay in ossification were observed. Pharmaceutical incompatibilities Not known. Shelf life 3 years. Do not use after the expiry date stated on the packaging. Storage conditionsStore at a temperature not exceeding +30°С. Keep out of the reach of children. Release conditions Released without a doctor’s prescription. PackingGel for external use in an aluminum tube, the tube, together with instructions for medical use, is packed in a cardboard box. Buy Dimestin gel 1mg/g 30g №1 Price for Dimestin gel 1mg/g 30g №1Instruction for use for Dimestin gel 1mg/g 30g №1
INN | DIMETINDEN |
---|---|
The code | 65 113 |
Barcode | 6 251 581 034 081 |
Dosage | 0.1% 30g |
Active substance | Dimetinden |
Manufacturer | Birzeit Pharmaceutical Company (BOD), Palestine |
Importer | IOOO Interfarmaks 223028 Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Star, 19a-5, room. 5-2 |
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